Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
NCT ID: NCT04183335
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2019-12-12
2022-02-03
Brief Summary
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To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable.
Secondary Objectives:
To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable.
To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dupilumab
Participants received dupilumab at a loading dose of 600 milligrams (mg), subcutaneously (SC) on Day 1 followed by dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.
Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Moisturizers
Pharmaceutical form:
Route of administration: Topical
Low to medium potent topical corticosteroids
Pharmaceutical form:
Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form:
Route of administration: Topical
Placebo
Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Moisturizers
Pharmaceutical form:
Route of administration: Topical
Low to medium potent topical corticosteroids
Pharmaceutical form:
Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form:
Route of administration: Topical
Interventions
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Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Moisturizers
Pharmaceutical form:
Route of administration: Topical
Low to medium potent topical corticosteroids
Pharmaceutical form:
Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form:
Route of administration: Topical
Eligibility Criteria
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Inclusion Criteria
With a clinical diagnosis of PN defined by all of the following:
* Diagnosed by a dermatologist for at least 3 months before the screening visit.
* On the worst-Itch Numeric Rating Scale (WI-NRS) ranged from 0 to 10, participants who had an average worst itch score of greater than or equal to (\>=) 7 in the 7 days prior to Day 1.
* Participants who had a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at screening visit and Day 1.
* History of failing a 2-week course of medium-to-superpotent TCS or when TCS were not medically advisable.
* Had applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.
* Was willing and abled to complete a daily symptom electronic-diary for the duration of the study.
Exclusion Criteria
* Presence of skin morbidities other than PN and mild atopic dermatitis (AD) that interfered with the assessment of the study outcomes.
* PN secondary to medications.
* PN secondary to medical conditions such as neuropathy or psychiatric disease.
* Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit.
* Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
* Severe renal conditions (eg, participants with uremia and/or on dialysis).
* Participants with uncontrolled thyroid disease.
* Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
* Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment had ruled out active infection before randomization.
* Active chronic or acute infection (except human immunodeficiency virus infection) required treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
* Known or suspected immunodeficiency.
* Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :8400011
Gilbert, Arizona, United States
Investigational Site Number :8400022
Fort Smith, Arkansas, United States
Investigational Site Number :8400026
Sacramento, California, United States
Investigational Site Number :8400014
Miami, Florida, United States
Investigational Site Number :8400004
Columbus, Georgia, United States
Investigational Site Number :8400003
Newnan, Georgia, United States
Investigational Site Number :8400017
Sandy Springs, Georgia, United States
Investigational Site Number :8400016
Indianapolis, Indiana, United States
Investigational Site Number :8400018
Clarkston, Michigan, United States
Investigational Site Number :8400013
St Louis, Missouri, United States
Investigational Site Number :8400024
East Windsor, New Jersey, United States
Investigational Site Number :8400009
Athens, Ohio, United States
Investigational Site Number :8400001
Dublin, Ohio, United States
Investigational Site Number :8400007
Tulsa, Oklahoma, United States
Investigational Site Number :8400010
Philadelphia, Pennsylvania, United States
Investigational Site Number :8400015
Charleston, South Carolina, United States
Investigational Site Number :8400006
Bellaire, Texas, United States
Investigational Site Number :8400025
Houston, Texas, United States
Investigational Site Number :8400002
Pflugerville, Texas, United States
Investigational Site Number :8400019
San Antonio, Texas, United States
Investigational Site Number :8400005
Norfolk, Virginia, United States
Investigational Site Number :0320008
CABA, Buenos Aires, Argentina
Investigational Site Number :0320005
CABA, Buenos Aires, Argentina
Investigational Site Number :0320002
CABA, Buenos Aires, Argentina
Investigational Site Number :0320004
CABA, Buenos Aires F.D., Argentina
Investigational Site Number :0320007
CABA, Buenos Aires F.D., Argentina
Investigational Site Number :0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number :0320001
Buenos Aires, , Argentina
Investigational Site Number :0320006
Caba, , Argentina
Investigational Site Number :0320009
Mendoza, , Argentina
Investigational Site Number :1560004
Beijing, , China
Investigational Site Number :1560001
Chengdu, , China
Investigational Site Number :1560002
Hangzhou, , China
Investigational Site Number :1560003
Wuxi, , China
Investigational Site Number :2500005
Reims, , France
Investigational Site Number :3920009
Yokohama, Kanagawa, Japan
Investigational Site Number :3920005
Kyoto, Kyoto, Japan
Investigational Site Number :3920007
Nagasaki, Nagasaki, Japan
Investigational Site Number :3920003
Tokorozawa-shi, Saitama, Japan
Investigational Site Number :3920010
Izumo-shi, Shimane, Japan
Investigational Site Number :3920004
Bunkyo-ku, Tokyo, Japan
Investigational Site Number :3920006
Itabashi-ku, Tokyo, Japan
Investigational Site Number :3920001
Shinagawa-Ku, Tokyo, Japan
Investigational Site Number :3920002
Nagoya, , Japan
Investigational Site Number :4840002
Guadalajara, Jalisco, Mexico
Investigational Site Number :4840001
Monterrey, Nuevo León, Mexico
Investigational Site Number :4840005
Monterrey, Nuevo León, Mexico
Investigational Site Number :4840006
Guadalajara, , Mexico
Investigational Site Number :4840003
Veracruz, , Mexico
Investigational Site Number :6430008
Chelyabinsk, , Russia
Investigational Site Number :6430007
Krasnodar, , Russia
Investigational Site Number :6430005
Moscow, , Russia
Investigational Site Number :6430010
Moscow, , Russia
Investigational Site Number :6430006
Moscow, , Russia
Investigational Site Number :6430002
Saint Petersburg, , Russia
Investigational Site Number :6430009
Saratov, , Russia
Investigational Site Number :6430001
Stavropol, , Russia
Investigational Site Number :4100007
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number :4100005
Incheon, Incheon-gwangyeoksi, South Korea
Investigational Site Number :4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number :4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number :4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number :4100001
Incheon, , South Korea
Countries
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References
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Kwatra SG, Yosipovitch G, Kim B, Stander S, Rhoten S, Ivanescu C, Haeusler N, Brookes E, Msihid J, Makhija M, Bansal A, Thomas RB, Bahloul D. Worst Itch Numeric Rating Scale for Prurigo Nodularis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2024 Aug 1;160(8):813-821. doi: 10.1001/jamadermatol.2024.1634.
Yosipovitch G, Mollanazar N, Stander S, Kwatra SG, Kim BS, Laws E, Mannent LP, Amin N, Akinlade B, Staudinger HW, Patel N, Yancopoulos GD, Weinreich DM, Wang S, Shi G, Bansal A, O'Malley JT. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023 May;29(5):1180-1190. doi: 10.1038/s41591-023-02320-9. Epub 2023 May 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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EFC16459 Plain Language Results Summary
Other Identifiers
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2019-003774-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1241-8153
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC16459
Identifier Type: -
Identifier Source: org_study_id
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